ISO 13485
  • ISO 13485 certification
  • Easy to use quality management system
  • Expert ISO Consultants

ISO 13485

ISO 13485: 2003 is the international quality management standard for the design and manufacture of medical devices. The current ISO 13485 standard is largely based on ISO 9001. The main differences between ISO 13485 and ISO 9001 are:

Continuous improvement is not a regulatory requirement; ISO 13485 requires the effectiveness of the QMS (Quality Management System) to be maintained.
Customer satisfaction is not a regulatory requirement, the goal being to provide safe and effective medical devices.

Certification to the ISO 13485 standard is particularly beneficial for organisations manufacturing medical devices but is also relevant to companies in the supply chain and offering service support to manufacturers.

If you export medical products and want to gain access to new markets, the standard provides a globally recognised quality system that may meet the market's requirements and save you valuable time and cost.

ISO 13485 will provide you with a QMS that will:

Demonstrate your commitment to product quality
Improve quality control
Manage risks
Comply with any legal and regulatory requirements
Provide better operational efficiency

ISO 13485 consultants

Your organisation will soon benefit from an effective quality system for medical devices that is both easy to use and highly effective. ISO 13485 consultancy covers the creation of procedures for internal audits, document control, records control, control of non-conforming products/services and corrective and preventive action. Records including calibration, training are each fully referenced or accessible from a ProActive web page or hyper-linked from an electronic quality manual within your Cert’N made easy package.

DAT Performance also provide ISO 13485 gap analysis services, internal audits and bespoke  consultancy services for clients wishing to improve, replace or integrate their existing ISO 9001 system with other standards such as ISO 14001, OHSAS 18001 or ISO 27001.

ISO 13485 management systems are prepared to the highest possible standard using down to earth and highly experienced consultants. They produce excellent results using a simple, jargon free methodology.

ISO 13485 Consultancy Outcomes

ISO 13485 certification (UKAS or other nationally accredited body)
Easy to use Quality Management System
Regulatory compliance
Reduced costs of failure, waste complaints etc.
Improved quality and service performance
Tender pre-qualification barriers removed
Enhanced reputation with existing and potential customers
Improved product and service reliability
Value added performance improvements

ISO 13485 history

ISO 13485 forerunner standards were EN46001 eventually becoming ISO 13485: 1996 based on the quality management standard ISO 9001: 1994. The current ISO 13485: 2003 is a single standard again largely based on ISO 9001